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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01951677




Registration number
NCT01951677
Ethics application status
Date submitted
16/09/2013
Date registered
27/09/2013
Date last updated
7/05/2019

Titles & IDs
Public title
Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine
Scientific title
Phase 1 Randomized, Controlled, Double-blind Study to Compare the Safety and Effectiveness of Hepatitis B Vaccines in Individuals With Renal Impairment, Diabetes Mellitus or Age Greater Than 40 Years
Secondary ID [1] 0 0
HBV002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exposure to Hepatitis B Virus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HBsAg
Other interventions - PreS HBsAg
Other interventions - Advax-1(TM)
Other interventions - Advax-2(TM)
Other interventions - Advax-3(TM)
Other interventions - Alum

Active Comparator: HBsAg + alum adjuvant - HBsAg + standard alum adjuvant

Experimental: HBsAg + Advax-1(TM) - HBsAg + Advax-1

Experimental: HBsAg + Advax-2(TM) - HBsAg + Advax-2

Experimental: HBsAg + Advax-3(TM) - HBsAg + Advax-3

Active Comparator: preS HBsAg + alum adjuvant - preS HBsAg + alum adjuvant

Experimental: preS HBsAg + Advax-1(TM) - preS HBsAg + Advax-1

Experimental: preS HBsAg + Advax-2(TM) - preS HBsAg + Advax-2

Experimental: preS HBsAg + Advax-3(TM) - preS HBsAg + Advax-3

Active Comparator: high dose preS HBsAg + alum adjuvant - high dose preS HBsAg + alum adjuvant

Experimental: high dose preS HBsAg + Advax-1(TM) - high dose preS HBsAg + Advax-1

Experimental: high dose preS HBsAg + Advax-2(TM) - high dose preS HBsAg + Advax-2(TM)

Experimental: high dose preS HBsAg + Advax-3(TM) - high dose preS HBsAg + Advax-3


Treatment: Drugs: HBsAg
Standard hepatitis B vaccine antigen

Other interventions: PreS HBsAg
preS hepatitis B surface antigen

Other interventions: Advax-1(TM)
Adjuvant formulated with vaccine antigen

Other interventions: Advax-2(TM)
Adjuvant formulated with vaccine antigen

Other interventions: Advax-3(TM)
Adjuvant formulated with vaccine antigen

Other interventions: Alum
Adjuvant formulated with vaccine antigen
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Hepatitis B surface antibody geometric mean titer
Timepoint [1] 0 0
one-month post each immunization and 10 months post-final immunization
Secondary outcome [2] 0 0
T cell responses
Timepoint [2] 0 0
7 days and one month post each immunization and 10 months post-final immunization
Secondary outcome [3] 0 0
Efficacy
Timepoint [3] 0 0
one month post each immunization and 10 months post final immunization

Eligibility
Key inclusion criteria
- Age 18 years and above

- Male or female

- Able to provide written informed consent

- Willing and able to comply with the protocol for the duration of the study.

- Has one or more of

- Age 40 years or above

- Impaired renal function (creatinine >120 mmol/L or calculated glomerular filtration
rate <60mls/min)

- Diagnosis of diabetes mellitus (any type)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of prior hepatitis B vaccination

- History of serious vaccine allergy if in the opinion of the Investigator this
represents a contraindication to hepatitis B vaccination

- Women of childbearing potential unless using a reliable and appropriate contraceptive
method, specifically oral contraceptive pill, intrauterine device or mechanical
barrier device.

- Pregnant or lactating women.

- History of systemic autoimmune disease including Wegener's granulomatosis, systemic
lupus erythematosus, Guillain-Barre, scleroderma or multiple sclerosis.

- Participation in another clinical trial with an investigational agent within 28 days
of the scheduled date of first immunization.

- Any other serious medical, social or mental condition that, in the opinion of the
investigator, would be detrimental to the subjects or the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2019
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders Medical Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
There is a need for more effective and better-tolerated hepatitis B vaccines for low
responder high-risk populations including patients with renal impairment and/or diabetes
mellitus and those aged over 40 years. Several approaches are available to enhance the
potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens,
replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine
antigen. A combination of these strategies is being tested in this study to identify the most
promising candidate approaches to take forward into advanced clinical development
Trial website
https://clinicaltrials.gov/ct2/show/NCT01951677
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Barbara, MBBS PhD
Address 0 0
Flinders Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01951677